Patient Monitoring System and Leadset Having Multiple Capacitive Patient Connectors and a Single Galvanic Patient Connector

ABSTRACT

A patient monitoring system having defibrillation protection includes a data acquisition device and a leadset. The data acquisition device records physiological signals from a patient, the data acquisition device having at least three receiving ports, each receiving port configured to connect to a patient connector. The leadset includes a galvanic patient connector that galvanically connects a first receiving port of the data acquisition device and the patient and at least a first capacitive patient connector and a second capacitive patient connector, wherein each capacitive patient connector capacitively couples a respective receiving port of the data acquisition device and the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 15/387,264, filed on Dec. 21, 2016, which is incorporatedherein by reference in its entirety.

BACKGROUND

This disclosure generally relates to medical monitoring systems anddevices, and more specifically to leadwires for ECG and/or respiratorymonitoring.

Electrocardiograms (ECGs) are graphic depictions of electrical activityin the heart, i.e. cardiac potentials. ECGs are produced byelectrocardiographs which are available as stand alone devices, portabledevices, and/or as integrated functions in various types of multi-vitalsign monitoring devices. ECGs are depicted by time (ms) versus voltage(mV) and typically are represented as a waveform. The typical fiveimportant aspects, or portions, of an ECG waveform are the P wave, QRScomplex (represented as the combination of the Q, R, and S wavesrespectively), and T wave. The less frequently seen sixth portion is a Uwave. The data produced from the graphical depictions are useful indiagnosis of patients to determine what, if any, and the extent to whichheart-related problems exist in a patient.

Respiration monitors are also available that use chest electrodes thatare similar or identical to ECG electrodes. For example, respirationrate measurement may be determined using impedance pneumography, where ahigh-frequency A/C current is passed between at least two electrodes(often the right arm electrode and left arm electrode), including adriving electrode and a receiving electrode, on the patient's chest andan impedance between the electrodes is determined. Respiration is thenmonitored according to the changing impedance values as the patientbreathes. As the patient inhales, air (which is an insulator) enters thelungs and causes the net impedance in the circuit to increase. When thepatient exhales, air leaves the lungs and causes the impedance in thecircuit to decrease.

Both electrocardiographs and respiration monitors (which may be separatedevices or contained in a single device using a common set ofelectrodes) must have protection circuitry to protect the electronics ofthose devices from high voltage exposure due to operation of adefibrillator on a patient to which the monitoring devices areconnected. Patients experiencing sudden cardiac arrest are treated witha defibrillation shock to the chest. The defibrillation shock istypically in the range of 3 to 5 kilovolts and 50amps, and typicallylasts between 5 and 20 milliseconds. Such a high voltage and current arenecessary in order to stop the patient's heart from unproductivefluttering (fibrillating) and to allow the heart to restart effectivepumping of blood. Typically, respiration monitors andelectrocardiographs are separate from the defibrillator device, and thechest electrodes and leadwires are connected to the patient when thedefibrillator delivers the shock. Thus, the electrocardiograph andrespiration monitors must withstand the significant voltage and currentof the defibrillation and continue working properly.

SUMMARY

This Summary is provided to introduce a selection of concepts that arefurther described below in the Detailed Description. This Summary is notintended to identify key or essential features of the claimed subjectmatter, nor is it intended to be used as an aid in limiting the scope ofthe claimed subject matter.

In one embodiment, a patient monitoring system comprises a dataacquisition device that records physiological signals from a patient,the data acquisition device having at least 3 receiving ports, eachreceiving port configured to connect to a patient connector. Themonitoring system further includes a galvanic patient connector thatgalvanically connects a first receiving port of the patient connectorand the patient, and at least a first capacitive patient connector and asecond capacitive patient connector. Each capacitive patient connectorcapacitively couples a respective receiving port of the data acquisitiondevice and the patient.

A respiration monitoring system comprises a data acquisition device thatrecords cardiac potentials from a patient, the patient monitoring havingat least three receiving ports that are each configured to connect to apatient connector. The system further includes a galvanic patientconnector that galvanically connects a first receiving port of the dataacquisition device and the patient, and at least a first capacitivepatient connector and a second capacitive patient connector. Eachcapacitive patient connector capacitively couples a respective receivingport of the data acquisition device and the patient. The cardiacpotentials are recorded from the patient between the first capacitivepatient connector and the second capacitive patient connector, and thegalvanic patient connector acts as a reference.

One embodiment of a lead set for recording physiological signals from apatient includes a galvanic patient connector comprising a conductiveleadwire and a galvanic electrode, and two or more capacitive patientconnectors. Each capacitive patient connector includes a capacitiveleadwire connecting to a galvanic electrode. The capacitive leadwireincludes an electrode end connecting to the galvanic electrode, a firstconductive layer extending from the electrode end, a device endconnectable to a data acquisition device, and a second conductive layerextending from the device end toward the electrode end. Wherein thecapacitive leadwire is configured such that the first conductive layeris galvanically isolated from the second conductive layer such that thefirst conductive layer and the second conductive layer form a capacitor.

Various other features, objects, and advantages of the invention will bemade apparent from the following description taken together with thedrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is described with reference to the followingFigures.

FIG. 1 depicts one embodiment of a patient monitoring system having asingle galvanic patient connector and multiple capacitive patientconnectors for recording physiological signals from a patient.

FIG. 2 depicts another embodiment of a patient monitoring systemincluding a data acquisition device with a defibrillation protectioncircuit and a leadset having a single galvanic patient connector andmultiple capacitive patient connectors for recording physiologicalsignals from a patient.

FIG. 3 is a graph depicting power measured at the output of a firstresistor typically provided at the front end of a defibrillationprotection circuit.

FIG. 4 is a graph depicting the power at the output of the firstresistor of the defibrillation protection circuit when a capacitiveleadwire of the present disclosure is utilized.

FIG. 5A depicts one embodiment of a capacitive patient connector.

FIG. 5B depicts one embodiment of a galvanic patient connector.

DETAILED DESCRIPTION

As described above, electrocardiographs and respiration monitors must beconfigured to withstand the high voltage defibrillation pulses, whichare on the order of 3 to 5 kilovolts and 50 amps and last for 5 to 20milliseconds (which is a long time for electronic components to survivesuch high voltage). Thus, such monitoring devices are typically providedwith defibrillation protection circuitry at their inputs which isdesigned to absorb the energy of the high voltage pulse before itreaches the sensitive electronics. Defibrillation protection inelectrocardiograph and respiration monitoring devices has traditionallybeen implemented with resistors, which are large and expensive becausethey must be designed to cope with huge defibrillation power surges.Additionally, resistive components introduce thermal noise. For example,the energy travelling through an average 10 kiloohm resistor from a 5kilovolt defibrillation pulse can cause the resistor to reach very hightemperatures, such as internal temperatures reaching 200° Celsius orhigher. This significant heating of the resistor causes it to breakdown.

The present inventors have recognized that the use of capacitive, ormore generally reactive, impedance in place of or in addition to suchpassive resistive components enables the use of high impedance levelswithout inherent noise issues. Accordingly, the present inventor is hasrecognized that capacitive patient connectors, such as capacitiveelectrodes or capacitive leadwires, can be utilized to protect againstthe defibrillation pulse. Additionally, the present inventors haverecognized that the leadwires, which connect chest electrodes on thepatient to data acquisition devices of patient monitors, can be createdso that the length of the leadwire provides capacitive transmission ofphysiological signals recorded at the electrode. This allows forinclusion of a relatively large capacitive element providing significantprotection against the defibrillation pulse without increasing theoverall size of the leadwire or the data acquisition device.

In addition to the electrically isolating properties of capacitivepatient connectors, the inventor has recognized that the use ofcapacitive electrodes has the added benefit of avoiding conductive gelsand pastes, such as silver/silver chloride gel, which are used intypical chest electrodes and are often irritating to the skin. Suchirritation can be especially problematic if the electrodes are to beworn by the patient over a long period of time, or if the patient hasparticular sensitivity or allergy to the conductive pastes and gelsutilized in conductive surface electrodes.

Capacitive patient connectors solve the aforementioned defibrillationresistor problems; however, the inventors have recognized thatcapacitive sensor topologies generally suffer from issues due tounreliability and low quality, especially for the purpose of diagnosticECG. For example, capacitive sensor topologies often have wandering andsuddenly changing DC offset. This can cause challenges when trying tokeep all of the recorded physiological signals in the correct DC offsetrange for the analog front end (AFE). Another problem with capacitivetopologies recognized by the inventors is that capacitive sensors do notprovide good coupling to the patient for the purposes of measuringchanges in impedance due to respiration.

In view of the recognition of the foregoing problems with capacitivetechnologies and their recognition of the benefits of capacitivelycoupling the patient to the data acquisition device, the inventorsdeveloped the solution disclosed herein where one single patientconnector in the lead set is resistive providing a DC path for ECGmonitoring and good coupling for impedance respiration, while theremainder of the patient connectors and the lead set are capacitive.Therefore, there is no current path with low resistance for thedefibrillator pulse to travel, but the DC offsets can still be managed.

Accordingly, in the system developed by the inventors, the dataacquisition device connects to one galvanic patient connector thatgalvanically connects the data acquisition device to the patient, andtwo or more capacitive patient connectors used to measure physiologicalpotentials from the patient, wherein each capacitive patient connectorcapacitively couples the data acquisition device to the patient. Thecapacitive patient connector may include a capacitive electrode thatcapacitively couples to a patient's skin, or could include a capacitivelead wire, which is described herein. In still another embodiment, acapacitor may be provided at the receiving port of the data acquisitiondevice 6, such as the initial element of the defibrillation protectioncircuit 8 in the analog front end 9.

FIG. 1 depicts one embodiment of a patient monitoring system 1 havingthree capacitive patient connectors 13 and a galvanic patient connector14 connecting the data acquisition device 6, which is a combinedrespiration monitor and ECG monitor, to the patient 40. Specifically,the capacitive patient connectors 13 comprise capacitive electrodes 3coupled to the patient's chest with conductive leadwires 2 b connectinga capacitive electrode 3 to the data acquisition device 6. Thecapacitive patient electrodes 3 are in the right arm position RA, theleft arm position LA, and the left leg position LL. The depictedelectrode arrangement is for purposes of explanation, and a personhaving ordinary skill in the art will understand in light of the presentdisclosure that any number of capacitive patient connectors 13 may beincluded and received by the data acquisition device 6. For example, in12 lead ECG applications ten electrodes may be used and connected to thedata acquisition device 6. In such embodiments, the defibrillationprotection circuit 8 in the analog front end 9 includes protectioncircuit elements for each input. The patient connectors 13, 14 may bedisposable elements or reusable elements, and in a preferred embodimentremovably connect to the data acquisition device 6, such as at areceptacle 37 in a housing of the data acquisition device 6.

The capacitive electrode 3 may be any capacitive electrode that usescapacitance for bioelectric measurement. A person having ordinary skillin the art will know that several different capacitive electrodesalready exist in the market. For example, the capacitive electrode maybe the QUASAR IBE by Quantum Applied Science and Research, Inc. of SanDiego, Calif. As described above, the capacitive electrode 3 may befixed directly to the patient's skin, and thus may touch the patient'sskin, or may be separated from the patient's skin by a material, such asa garment or a band to which the capacitive electrode may be fixed.

The data acquisition device 6 may be any type of physiologicalmonitoring device involving electrodes to the patient, especially thoseinvolving chest electrodes where defibrillation protection is required.For example, the data acquisition device 6 may be an ECG monitor thatrecords cardiac potentials from the patient or a respiratory monitor,such as an impedance pneumograph, that records physiological potentialsrelevant to respiratory monitoring. The data acquisition device 6 servesto collect the physiological data recorded from the patient 40 and storeor transmit the physiological data to a hub device, central dataacquisition device, or host network for the medical facility. In thedepicted embodiment, the data acquisition device 6 has a processor 10that receives digitized physiological data from the analog front end 9,and controls a wireless interface 12 to transmit the physiological datafor further processing and/or storage in a patient's medical record.

As discussed above, capacitively coupling the patient 40 to the dataacquisition device 6 via capacitive patient connectors leads toperformance issues due to DC drift. For example, the static potential ofthe patient's body will change as the patient moves, and such changescan happen quite quickly. This changing DC potential can saturate theamplifiers, which temporarily inhibits reliable patient monitoring. Innormal patient monitoring using galvanic electrodes, such as standardECG monitoring, the body potential is typically set to a certain DCpotential, or offset voltage. However, that control of the DC potentialdoes not occur in a purely capacitive coupling situation.

Accordingly, the present inventors developed the depicted embodimentwhere one, and only one, galvanic patient connector 14 is provided thatserves as a single DC reference electrode that galvanically connects tothe patient, thus serving as a reference electrode to remove DC drift,and thus improve performance of the data acquisition device byeliminating the noise and amplifier saturation issues. Further, thesingle galvanic patient connector 14 allows respiration measurement byserving as a ground when the high frequency current is driven throughthe capacitive patient connectors 13 for the purpose of monitoringrespiration potentials.

FIG. 1 provides a schematic diagram of one possible configuration forutilizing the galvanic patient connector 14 as a reference electrode.Each of the three lead channels are added by the summing circuit 122 tocreate a patient common mode voltage. In various embodiments, thegalvanic patient connector 14 may simply provide a passivelow-resistance path to ground, or it may be connected to an activecircuit in the data acquisition device 6 (such as in the AFE), oftenreferred to as a “right leg driver.” In such an embodiment, as depicted,the common mode voltage output of the summing circuitry 122 drives aninverting amplifier 124, which in turn drives the galvanic patientconnector 14. In the depicted embodiment, the galvanic patient connector14 includes a galvanic electrode 4 connected to the patient 40 at theright leg position RL. Thereby, the galvanic electrode 4 in the rightleg position RL acts to subtract the common mode noise, includingproviding DC offset subtraction.

In other embodiments, the galvanic patient connector 14 may provide apassive path to ground. For example, the system 1 in FIG. 1 may provideimpedance respiration monitoring, such as by monitoring the change inresistance to a drive current between the capacitive electrode 3 in theright arm position RA and in the left leg position LL, where thegalvanic patient connector 14 provides a ground for that drive currentdelivered by the capacitive electrodes 3. As described above, the drivecurrent has a carrier frequency that corresponds with the value.

FIG. 2 depicts another embodiment where the capacitive patientconnectors 13 comprise capacitive lead wires 2 a, rather than capacitiveelectrodes 3. The capacitive patient connector 13 includes a galvanicelectrode 4, such as a standard chest electrode adhering to the patientwith silver/silver chloride gel, and a capacitive leadwire thatcapacitively couples the galvanic electrode 4 (which is attached to thepatient) and a receptacle 37 of the data acquisition device 6.

FIGS. 4A-4D depict various embodiments of the capacitive leadwire 2. Ingeneral, the capacitive leadwire 2 has a first conductive layer 21 and asecond conductive layer 22 that are galvanically isolated and form acapacitor along the length of the capacitive leadwire 2 a. For example,the first conductive layer 21 and the second conductive layer 22 may beparallel wires divided by a substrate 24, which is an insulator havingknown dielectric properties. The first conductive layer 21 extends fromthe electrode end 44 of the capacitive leadwire 2 a, and is in galvaniccontact with a conductive portion 5 of the chest electrode 4. The firstconductive layer 21 extends along at least a portion of the length ofthe capacitive leadwire 2 a, and in many embodiments extends for amajority of the length of the capacitive leadwire 2 a. The secondconductive layer extends from the device end 46 of the capacitiveleadwire 2 a. The second conductive layer 22 also extends at least aportion of the length of the capacitive leadwire 2 a so that its lengthsufficiently intersects the length of the first conductive layer 21 sothat the two layers can form a capacitor C_(L).

As depicted in FIG. 5A, for example, the cross over area between thefirst conductive layer 21 and the second conductive layer 22 form acapacitor C_(L) that may span a majority of the length of the capacitiveleadwire 2 a. In other embodiments, the capacitive area C_(L) may belarger or smaller compared to the total length of the leadwire 2 a. Inthe embodiments depicted and described, the capacitance of thecapacitive aspect C_(L) of the leadwire 2 a can be adjusted andcontrolled by adjusting the area of overlap between the conductivelayers 21 and 22 and adjusting the separation between the conductivelayers 21 and 22. Furthermore, the capacitance is also affected by thepermittivity of the material comprising the substrate 24 between theconductive layers 21 and 22.

FIG. 2 depicts a circuit diagram of an exemplary defibrillationprotection circuit 8 provided at the input of a data acquisition device6 for acquiring cardiac or respiration signals from a patient, andcapacitive leadwires 2 that are connectable to the defibrillationprotection circuit. The capacitive leadwires 2 connect chest electrodes4 to the data acquisition device, where the defibrillation protectioncircuit 8 resides as a front end protection circuit. In the example,three chest electrodes 4 are depicted for purposes of explanation, whichinclude the left arm electrode LA, right arm electrode RA, and right legelectrode RL. As will be understood by a person having ordinary skill inthe art in light of this disclosure, any number of electrodes may beincluded and received by the data acquisition device 6. For example, in12-lead ECG applications ten or more electrodes may be used andconnected to the data acquisition device 6. In such embodiments, thedefibrillation protection circuit 8 includes protection circuit elementsfor each input. The leadwires 2 may be disposable elements or reusableelements, and in a preferred embodiment removably connect to the dataacquisition device 6, such as at a receptacle 37 in a housing of thedata acquisition device 6.

In the depicted example, the defibrillation protection circuit 8provided at the front end of the data acquisition device 6 includes aresistor R₁ at the galvanic connection point of each receptacle 37. Forexample, the resister R₁ may be in the range of 10 to 20 kiloohms, oreven as high as 100 kiloohms. For each input, the resistor R₁ may beconnected in series with one or more voltage absorption elements I₁ andI₂, which are configured to absorb at least a portion of the energyexiting the resistor R₁ during a defibrillation event. For example, I₁and I₂ may be neon glow lamps, where a small radioactive dot inside agas tube provides photons to stabilize the ionization voltage. Such neonglow lamps are commonly used in defibrillation protection circuits 8.Alternatively, I₁ and I₂ may be gas-discharge arrestor tubes ortransient voltage suppressors, which are also known to be used for suchpurposes.

Resistors R₂ and R₃, along with capacitors C₁, C₂, and C₃ form low passfilters for each input. The diode D₁ limits the voltage to a lowerlevel. For example, diode D₁ may be a Zener diode or an Avalanche diode,a metal oxide varistor, or a thyristor surge protector. The diode D₁ inconjunction with the capacitor C₁ provide the first part of a low passfilter. Capacitor C₂ acts as a common-mode filter, and capacitor C₃provides differential filtering. Typically, capacitor C₃ is about tentimes larger than capacitor C₂. A high-voltage signal-line protector SW₁follows the low pass filter and is a switch that senses high voltage andturns on a clamp to reduce the amount of voltage permitted to reach therespective amplifier. In alternative embodiments, the current limitingelement may instead be a current-limiting diode. D₁ odes D₂ and D₃ areelectrostatic discharge protection diodes that clamp the amplifier inputto the power supplies. Capacitor C₄ and Zener diode D₆ are connected tothe amplifiers to absorb and clamp the positive voltage rail. CapacitorC₅ and Zener diode D₇ are also connected to the amplifiers in order toabsorb and clamp the negative voltage rail.

The embodiment of FIG. 2 is depicted as including galvanic electrodes 4at the left arm position LA and right arm position RA, and a galvanicpatient connector having a galvanic electrode 4 at the right legposition RL. The amplifier A₁ puts an output potential based on the leftarm and right arm inputs. As described above, in an embodimentcomprising an active circuit that drives the reference lead, which inthe depicted embodiment is the right leg electrode RL, the output of A₁is summed with other output potentials from other leads and provided tothe amplifier A_(G), which as described above is an inverting amplifierthat drives the right leg electrode RL. It should be noted that, whilethe depicted embodiments show the galvanic electrode 4 of the galvanicpatient connector 14 connected at the right leg position RL, thegalvanic patient connector may connect at any other location on thepatient 40.

The defibrillation protection circuit 8 may be incorporated in orfollowed by an analog front end 9 (AFE) which filters and digitizes theanalog signals that emerge from the defibrillation protection circuit 8.Various analog front end designs are well known. In certain embodiments,the defibrillation protection circuit 8 and the analog front end 9 maybe integrated into a single device or arrangement.

The inventors of the present application have recognized that suchdefibrillator protection circuits may be insufficient for providingprotection from defibrillation pulses, especially as data acquisitiondevices 6 become smaller and it is desired to reduce the size of thecomponents and the overall circuit. Accordingly, the inventors haveendeavored to provide a more robust defibrillation protection systemthat reliably incorporates capacitive patient connectors in order toisolate the data acquisition device 6 from defibrillation pulses. Forexample, in the context of wireless patient monitoring, it is desirableto provide a data acquisition device 6 that can be worn by or attachedto the body of a patient. In such an embodiment, it is desirable toprovide a small and light data acquisition device 6 that can wirelesslytransmit physiological data gathered from the patient, such as ECG dataor respiration data, to a hub device or host computer network associatedwith the patient physiological monitoring system.

Comparison between the graphs of FIGS. 3 and 4 exemplifies the benefitof using the capacitive patient connectors 13 described herein. FIG. 3depicts the power transferred through the 10 kiloohm resistor R₁, whichis a typical resistor provided at the input of a defibrillationprotection circuit 8, during a 5 kilovolt pulse, which represents atypical defibrillation pulse that might be administered to a patientexperiencing cardiac arrest. As can be seen, the resistor R₁ encountersabout 2.5 kilowatts of power instantaneously at the start of thedefibrillation pulse and experiences that power for the duration of thepulse. In the depicted embodiment where the pulse has a duration ofapproximately 5 milliseconds, the energy transferred through theresistor R₁ approaches 13 joules, which is a very large amount of energyin a very short period of time.

This can be compared to the graph in FIG. 4, where the same 5 kilovolt,5 millisecond pulse is input to a system having a capacitive leadwire 2a connecting between the electrode absorbing the pulse from thepatient's chest and the data acquisition device 6. In the depictedembodiment, the capacitor C_(L) formed by the capacitive leadwire 2 ahas a 100 picofarad capacitance. As demonstrated in the graph, the powermeasured at the output of the resistor R₁ is minimal compared to theconfiguration without the capacitive leadwire C_(L), where the powerthrough resistor R₁ peaks at about 250 milliwatts at the beginning andend of the defibrillation pulse, and the total energy through theresistor R₁ is only about 50 microjoules. Thus, the resistor R₁ will notexperience heating, and the size of the resistor can even be decreasedif desired. The depicted test pulse has a 0.1 millisecond rise and falltime, meaning that the capacitor C_(L) has time to adjust. However, evenif the rise time is much shorter, such as 1 microsecond, the totalenergy still remains below 2 millijoules, which is still a significantdecrease from the 13 joules of energy without the capacitive leadwire 2.

When using the capacitive leadwire 2, the capacitive value of capacitorC_(L) may be adjusted to ensure that the target frequencies aretransmitted and are not filtered out. For example, when utilizing thecapacitive leadwire 2 for monitoring respiration, one needs to utilize ahigh enough carrier frequency that will not be filtered out by thecapacitor. For instance, if the carrier frequency is 50 kilohertz (whichis common in respiration monitoring), one would use 1 nanofaradscapacitor C_(L). In certain applications, it may be desirable to utilizea higher carrier frequency, such as 1 megahertz, and decrease value ofthe capacitor C_(L) to 100 picofarads.

In certain embodiments, the capacitive leadwire 2 a and/or theconductive leadwire 2 b may be formed by printing the conductive layers21 and 22 on a substrate 24. For example, the conductive layers 21 and22 may be conductive traces printed on the substrate 24 with conductiveink. Conductive ink is a liquid ink dispensable by a specialized printerto form an object that conducts electricity. The transformation fromliquid ink to a solid conductor may involve a drying or curing process.Such inks allow circuits to be drawn or printed on a variety ofsubstrate material, and typically contain conductive materials such aspowdered or flaked silver and carbon-like materials, although polymericconduction is also known. As will be understood by a person havingordinary skill in the art in view of this disclosure, a number ofconductive inks are available and appropriate for printing a conductivetrace onto a flexible substrate 24 to provide a continuous conductor ofa predefined length. The conductive portion 5 of the galvanic electrode4 may also be printed, such as on the substrate material 24.

The flexible substrate 24 may be comprised of any number of materials.In one embodiment, the flexible substrate 24 is a thermal plasticpolyurethane (TPU). Alternatively, the flexible substrate 24 may be apolyethylene terephthalate (PET), or any other plastic materialsufficiently flexible to be used as a substrate for purposes ofproviding a leadwire connecting between an electrode and a dataacquisition device 6.

FIG. 5A depicts one embodiment of a printed capacitive patient connector13, and FIG. 5B depicts one embodiment of a printed galvanic patientconnector 14. In FIG. 5A, the first conductive layer 21 and the secondconductive layer 22 are printed on a first side 25 of a substrate 24.The conductive layers 21 and 22 are parallel printed traces, with thefirst conductive layer 21 extending from the electrode end 44 and thesecond conductive layer 22 extending from the device end 46 of thecapacitive leadwire 2 a. As described above, the first conductive trace21 may extend to a conductive portion 5 of an electrode 4, which mayalso be a printed element.

The first conductive layer 21 is printed on a first side 25 of the stripof substrate 24, which is for example a long and thin strip of TPU. Thefirst conductive layer is, for example, a first trace printed on thebottom side 25 starting at the electrode end 44 of the leadwire 2 andcontinuing most of the length of the leadwire 2, as is depicted. Asecond conductive layer 22 is also printed on the first side 25 of thestrip of substrate 24. The second conductive layer extends from thedevice end 46 of the leadwire 2 across most of the length of theleadwire. Accordingly, the first conductive layer 21 and the secondconductive layer 22 are separated by the substrate material 24, and thusare galvanically isolated. The mutual capacitance between the twoadjacent parallel conductive layers 21 and 22 transmits thephysiological signals recorded from the patient during normal monitoringoperation. However, upon delivery of a defibrillation pulse, thecapacitor C_(L) saturates in the voltage across the capacitor C_(L) iseffectively zero. This is demonstrated in FIG. 3, where the capacitorC_(L) blocks transmission of the of the high voltage defibrillationpulse.

The electrode end 44 in the embodiment of FIGS. 5A and 5B could beprovided with an element to connect to an electrode, or an electrodecould be formed or attached by any means. Alternatively, the electrodemay be provided with attachment means, such as a clip capable ofpuncturing any insulation layer and making galvanic connection to thefirst conductive layer 21.

The geometry of the conductive layer 21, 22 and their arrangement may bevaried, whether in a printed embodiment or in a leadwire 2 a, 2 bconstructed by other means. For example, the conductive layers 21, 22may be plate-like, being relatively narrow (such as a width of 1-3centimeters) and long (such as 1-3 feet) extending the length of theleadwire 2. In another embodiment, the second conductive layer 22 isprinted on a second side of the strip of substrate 24, such as on thetop, or opposite, side as the first conductive layer 21. In still otherembodiments, the first conductive layer 21 and the second conductivelayer 22 may be arranged in a coaxial configuration where one of theconductive layers 21, 22 forms a cylinder surrounding the otherconductive layer 21, 22, which is a cylindrical wire, with the substratematerial 24 dividing the two layers.

A printed galvanic patient connector 14 similarly includes a conductivelayer printed on a first side 25 of the strip of substrate 24. Asdescribed above, the depicted embodiments provide a printed galvanicelectrode 4 having a conductive portion 5 that galvanically connects tothe patient 40, such as by the use of silver/silver chloride gel. Theconductive portion 5 is also printed. Other elements may also be printedalong the length of the leadwire 2 b, such as resistive traces or othercircuit elements. For example, resistor R₁ may be built into theleadwire 2 b rather than being incorporated into the defibrillationprotection circuit 8 provided in the data acquisition device 6. Forexample, resistor R₁ may be a printed element printed on a top side 26of the substrate 24. In the embodiment of FIG. 4B, the resistor isprinted near the device end 46 of the leadwire 2 and is contained withinthe device connector 35, which is an element configured to be receivedby and attached to the receptacle 37 of the data acquisition device 6.In other embodiments, the resistor R₁ may be printed on a portion of theleadwire 2 that is outside of the device connector 35, and may beanywhere between the capacitor portion C_(L) of the leadwire 2 and thedevice end 46. In still other embodiments, the resistor printed on thesecond conductive layer 22 may be in addition to the resistor R₁ of thedefibrillation protection circuit 8, and thus may be in seriestherewith.

Additionally, an insulating layer may be provided over the conductivelayers in order to shield them from noise induced by other magneticfields, which are common in hospital and healthcare environments. Theinsulating layer may be printed over the conductive layers 21, 22, orapplied over the conductive layers 21, 22 by other means. For example,the insulating layer may be a separate piece of material adhered to thefirst side 25 of the substrate 24. For instance, the insulating layermay be comprised of the same material as the flexible substrate 24, suchas TPU or PET, or may be any other material that sufficiently insulatesthe conductive layers 21, 22 from noise. For instance, the printedinsulating layer may be comprised of ElectrodagPF-455B UV-CurableInsulator Paste by Henkel Corporation or may be 125-17M Screen-PrintableUV-Curable Coating by Creative Materials, Inc.

In other embodiments, the electrode end 44 of the respective leadwire 2a, 2 b may be provided with an electrode connector configured to connectto any galvanic electrode 4. For example, the electrode connector may bea snap connector configured to connect with a snap electrode. In otherembodiments, the electrode connector may be any element capable ofgalvanically connecting to the electrode 4, such as an alligator clip orclamp.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to make and use the invention. Certain terms have been used forbrevity, clarity and understanding. No unnecessary limitations are to beinferred therefrom beyond the requirement of the prior art because suchterms are used for descriptive purposes only and are intended to bebroadly construed. The patentable scope of the invention is defined bythe claims, and may include other examples that occur to those skilledin the art. Such other examples are intended to be within the scope ofthe claims if they have features or structural elements that do notdiffer from the literal language of the claims, or if they includeequivalent features or structural elements with insubstantialdifferences from the literal languages of the claims.

We claim:
 1. A patient monitoring system having defibrillationprotection, the patient monitoring system comprising: a data acquisitiondevice that records physiological signals from a patient, the dataacquisition device having at least three receiving ports, each receivingport configured to connect to a patient connector; a leadset comprising:a galvanic patient connector that galvanically connects a firstreceiving port of the data acquisition device and the patient; and atleast a first capacitive patient connector and a second capacitivepatient connector, wherein each capacitive patient connectorcapacitively couples a respective receiving port of the data acquisitiondevice and the patient.
 2. The patient monitoring system of claim 1,wherein the physiological signals recorded from the patient are cardiacpotentials between the first capacitive patient connector and the secondcapacitive patient connector; and wherein the galvanic patient connectoracts as a reference electrode.
 3. The patient monitoring system of claim2, further comprising at least a third capacitive patient connector;wherein the first capacitive patient connector is connected at a rightarm location on the patient, the second capacitive patient connector isconnected at a left arm location on the patient, the third capacitivepatient connector is connected at a left leg location on the patient,and the galvanic patient connector is connected at a right leg locationon the patient.
 4. The patient monitoring system of claim 1, wherein thephysiological signals recorded include respiration potentials betweenthe first capacitive patient connector and the second capacitive patientconnector; and wherein the first capacitive patient connector and thesecond capacitive patient connector are drive electrodes to inject an ACcurrent into the patient, and the galvanic patient connector acts as aground.
 5. The patient monitoring system of claim 1, wherein the firstcapacitive patient connector includes a first capacitive electrode and afirst leadwire configured to connect the first capacitive electrode tothe respective receiving port; and wherein the second capacitive patientconnector includes a second capacitive electrode and a second leadwireconfigured to connect the second capacitive electrode to the respectivereceiving port.
 6. The patient monitoring system of claim 1, wherein thefirst capacitive patient connector and the second capacitive patientconnector each include a capacitive leadwire configured to connect to agalvanic electrode, the capacitive leadwire comprising: an electrode endconfigured to connect to the galvanic electrode; a first conductivelayer extending from the electrode end; a device end connectable to adata acquisition device; a second conductive layer extending from thedevice end; and wherein the first conductive layer is galvanicallyisolated from the second conductive layer such that the first conductivelayer and the second conductive layer form a capacitor.
 7. The patientmonitoring system of claim 6, wherein the first conductive layer and thesecond conductive layer are parallel wires divided by a substrate. 8.The patient monitoring system of claim 7, wherein the first conductivelayer and the second conductive layer are comprised of a conductive inkprinted on a substrate.
 9. The patient monitoring system of claim 8,wherein the galvanic patient connector includes a conductive leadwireconfigured to connect to a galvanic electrode, wherein the conductiveleadwire is comprised of a conductive ink printed on a substrate, andfurther comprising a resistor of at least 1 kilo-ohm printed on theconductive leadwire.
 10. The patient monitoring system of claim 1,wherein the data acquisition device is a 12 lead electrocardiograph thatrecords cardiac potentials from the patient, the 12 leadelectrocardiograph having 10 receiving ports; and wherein the leadsetincludes the galvanic patient connector and nine capacitive patientconnectors.
 11. A respiration monitoring system having defibrillationprotection, the respiration monitoring system comprising: a dataacquisition device that records cardiac potentials from a patient, thedata acquisition device having at least three receiving ports, eachreceiving port configured to connect to a patient connector; a galvanicpatient connector that galvanically connects a first receiving port ofthe data acquisition device and the patient; at least a first capacitivepatient connector and a second capacitive patient connector, whereineach capacitive patient connector capacitively couples a respectivereceiving port of the data acquisition device and the patient; whereinthe cardiac potentials are recorded from the patient between the firstcapacitive patient connector and the second capacitive patientconnector; and wherein the galvanic patient connector acts as areference.
 12. The respiration monitoring system of claim 11, furthercomprising at least a third capacitive patient connector; wherein thefirst capacitive patient connector is connected at a right arm locationon the patient, the second capacitive patient connector is connected ata left arm location on the patient, the third capacitive patientconnector is connected at a left leg location on the patient, and thegalvanic patient connector is connected at a right leg location on thepatient.
 13. The respiration monitoring system of claim 12 wherein thegalvanic patient connector is utilized to remove artifact caused by achange in a DC offset in the cardiac potentials recorded between theeach of the capacitive patient connector, the second capacitive patientconnector, and the third capacitive patient connector.
 14. Therespiration monitoring system of claim 11, wherein the first capacitivepatient connector includes a first capacitive electrode and a firstleadwire connecting the first capacitive electrode to the respectivereceiving port; and wherein the second capacitive patient connectorincludes a second capacitive electrode and a second leadwire connectingthe second capacitive electrode to the respective receiving port. 15.The respiration monitoring system of claim 14, wherein the firstcapacitive patient connector and the second capacitive patient connectoreach include a capacitive leadwire configured to connect to a galvanicelectrode, the capacitive leadwire comprising: an electrode endconfigured to connect to the galvanic electrode; a first conductivelayer extending from the electrode end; a device end connectable to adata acquisition device; a second conductive layer extending from thedevice end toward the electrode end; and wherein the first conductivelayer is galvanically isolated from the second conductive layer suchthat the first conductive layer and the second conductive layer form acapacitor.
 16. The respiration monitoring system of claim 15, whereinthe first conductive layer and the second conductive layer are parallelwires divided by a substrate.
 17. A leadset for recording physiologicalsignals from a patient, the leadset comprising: a galvanic patientconnector comprising a conductive leadwire and a galvanic electrode; andat least two capacitive patient connectors, wherein each capacitivepatient connector includes a capacitive leadwire configured to connectto a galvanic electrode.
 18. The leadset of claim 17, wherein eachcapacitive leadwire comprises: an electrode end connecting to thegalvanic electrode; a first conductive layer extending from theelectrode end; a device end connectable to a data acquisition device; asecond conductive layer extending from the device end toward theelectrode end; and wherein the first conductive layer is galvanicallyisolated from the second conductive layer such that the first conductivelayer and the second conductive layer form a capacitor.
 19. The leadsetof claim 18, wherein the first conductive layer and the secondconductive layer are parallel wires divided by a substrate.
 20. Theleadset of claim 18, wherein the first conductive layer and the secondconductive layer are comprised of a conductive ink printed on asubstrate.